Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing
FDA device recall Z-0985-05 · posted 2005-07-13 · Terminated
Recall details
- Recalling firm
- Natus Medical Inc
- Reason for recall
- Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.
- Action taken
- The firm plans to provide corrections via removal/replacement of the affected units directly to end users in the U.S. and work with distributors to perform removal and correction abroad.
- Root cause
- Other
- Status
- Terminated
- Product code
- ETY
- Quantity affected
- 2473 units
- Distribution
- Product was distributed worldwide, to distributors in Canada, Australia/New Zealand, Japan, the European Union, Bahamas, Bermuda, Chile, China, Hong Kong, INdia, Indonesia, Israel, Italy, Kuwait, Luxe
- Date initiated
- 2005-06-27
- Date posted
- 2005-07-13
- Date terminated
- 2006-01-09
- Location
- San Carlos, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALGO 3I NEWBORN HEARING SCREENER (K030823) | Natus Medical, Inc. | 2003-04-09 |
| ALGO 3 NEWBORN HEARING SCREENER (K013137) | Natus Medical, Inc. | 2001-10-16 |
| ALGO-2 NEWBORN HEARING SCREENER (K936039) | Natus Medical, Inc. | 1995-01-05 |
| ALGO I (K852687) | Algotek, Inc. | 1985-09-18 |